The organization shall plan and control the design and development of product.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

(From BS EN ISO 9001:2000)

As is evident from the title of this clause, planning is key to the successful design of any project and an important element of ISO 9001:2000. This clause states that an organization must have a specified route to achieve the end goal of each project and, of course, an end goal that is clear to everyone as well.

This isn't anything new to business, or life in general. For example, let's say that you want to build a table for your home. You'll need to do some planning before you begin purchasing wood and other materials, and you'll also need to answer some questions, such as:

• What is the purpose of the table?
• What will be the development phases of building the table?
• Should you build a prototype of the table or just begin the project?
• How will you test the table's functionality before using it in your home?

You get the point. Planning is necessary for a successful project. However, this clause is not intended to be a big paperwork exercise. The level of detail is up to each organization. In fact, the clause does not require a procedure or that records be kept for 7.3.1, although having both is a good idea. (Note: "Planning output" must be updated, as appropriate, as design progresses. To some auditors, that implies some type of evidence that the planning was performed and updated as appropriate. Organizations should keep that in mind when addressing this clause.)

One good way to address project planning is through the use of flowcharts. Using diagrams and flowcharts to show the entire project plan and its process also creates documentation, which helps an organization manage risk. Additionally, flowcharts are easy to update or change as the project progresses, which is also a requirement of this clause. Items that you should consider when creating a project flowchart are: project description, affected personnel, delivery dates of the plan's elements, resources and other relevant information concerning how the plan will proceed through completion.

This clause also requires that organizations consider the review, verification and validation of each stage of the project plan. In other words, tests should be conducted periodically and as appropriate to measure the functionality of the product to ensure it performs to the proper specification.

Additionally, although a procedure isn't a requirement for this clause, you should consider creating one if you don't have one. Doing so is a good insurance policy, because if a design is bad, you can fix the process a lot easier if it's mapped out and documented.